UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetic study of CNT-01 in healthy adults (Phase I study)
Title of the study (Brief title)	Pharmacokinetic study of CNT-01 in healthy adults (Phase I study)
Region	Japan

Condition
Condition	Idiopathic triglyceride deposit cardiomyovasculopathy
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess pharmacokinetics and safety of CNT-01 following a single oral dose administration in healthy adults
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Area under the plasma concentration-time curve (AUC0-inf)
Key secondary outcomes	- Maximum plasma concentration (Cmax) - Time to maximum plasma concentration (tmax) - Elimination half-life (t1/2) - Area under the plasma concentration-time curve (AUClast) - Change in plasma concentration - Linearity of AUC0-inf vs. dose - Safety (Adverse events, adverse drug reactions and laboratory tests)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Sequential single oral escalating doses of CNT-01(250mg, 500mg and 2000mg) under fasting condition followed by CNT-01 500mg under fed condition
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Gave written informed consent after receiving a sufficient explanation upon participation in the study 2) Between the ages of 20 and 65 at the time of obtaining informed consent 3) Body weight more than 45 kg, height taller than 140 cm and Body Mass Index (BMI) between 17.5 kg/m2 and 30.0 kg/m2 at screening 4) Are able to abstain from smoking throughout the duration of the study 5) Are able to follow the protocol, undergo consultation/examination as described in the protocol and report their symptoms 6) Underwent screening tests within one month before investigational product (IP) administration and judged eligible by the investigator
Key exclusion criteria	1) Have a medically significant complication such as digestive, renal, respiratory, endocrine, hematologic, nervous, psychiatric and cardiovascular disorder and inborn errors of metabolism 2) Had an acute disease within 2 weeks before IP administration (e.g., stomachache, nausea, vomiting, anorexia, fever) 3) Took a prescription drug, over the counter drug, nutrient, vitamin or herbal preparation (including Chinese medicine) within 2 weeks before IP administration 4) Have a present condition or known history of drug or food allergy 5) Participated or are currently participating in another clinical study or post-marketing clinical trial within 3 months before IP administration 6)Ingested any medicine, food or beverage (e.g., coffee, tea, chocolate, coke) containing methylxanthine such as caffeine within 48 hours before IP administration 7)Subjects with or suspected of alcohol or drug abuse at screening 8)Ingested any food or beverage containing grapefruit juice, grapefruit, St. Johns wort or Seville orange within 72 hours before IP administration 9) Fall under any of the following -received blood transfusion within 3 months before IP administration -donated whole blood more than or equal to 400 mL within 3 months before IP administration -donated whole blood more than or equal to 200 mL within a month before IP administration -donated blood component within 2 weeks before IP administration 10) Had an infection requiring treatment within a month before IP administration 11) Diagnosed with AIDS or HIV positive 12) Positive for HBs antigen, HCV antibody or syphilis serology test 13) Have eGFR less than 60.0 mL/min/1.73 m2 at screening 14) Women who are or may be pregnant, who are unable to practice contraception properly (e.g., avoiding sexual intercourse, using an intrauterine device) within 12 weeks after IP administration or who are lactating 15) Employed by the CRO related to the study or the medical institution 16) Considered unfit for the study by the investigator
Target sample size	6

Research contact person
Name of lead principal investigator	Tomoko Hasunuma
Organization	Oita University Hospital
Division name	Clinical Pharmacology Center
Address	1-1 Idaigaoka, Hasama-machi, Yufu city, Oita 879-5593, JAPAN
TEL	+81-97-586-5952
Email	hasunuma@oita-u.ac.jp

Public contact
Name of contact person	Naoto Uemura
Organization	Oita University Hospital
Division name	Clinical Pharmacology Center
Address	1-1 Idaigaoka, Hasama-machi, Yufu city, Oita 879-5593, JAPAN
TEL	+81-97-586-5952
Homepage URL
Email	uemura@oita-u.ac.jp

Sponsor
Institute	Oita University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Osaka University Hospital
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大分大学医学部附属病院　　　　　　　　　　　　　　　　　　　　　　Oita University Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 28 Day
Anticipated trial start date	2016 Year 05 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 02 Day
Last modified on	2016 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025419